Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084557
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/29/1975 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/01/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/15/1987 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

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